PROAIR DIGIHALER (albuterol sulfate) · Teva
PROAIR DIGIHALER is FDA-approved to treat 3 conditions (same as PROVENTIL-HFA).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2015-03-31
- Routes
- INHALATION
- Dosage Forms
- POWDER, METERED
PROAIR DIGIHALER Approval History
What PROAIR DIGIHALER Treats
3 indicationsPROAIR DIGIHALER is approved for 3 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bronchospasm
- Obstructive Airway Disease
- Exercise-Induced Bronchospasm
Same approved indications as PROVENTIL-HFA (same active ingredient).
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07426458 | 20251152 | Ph 4 | recruiting | Ventilation and Perfusion in Asthmatics |
| NCT06052267 | FpA-AS-30094 2023-505435-12-00 | Ph 3 | active not recruiting | A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations |
| NCT05035862 | STUDY00002655 2709 | Ph 1 | terminated | Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma |
| NCT02969408 results posted | ABS-AS-30064 | Ph 3 | completed | A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma |
| NCT03586544 results posted | 1131374-2 | Ph 4 | terminated | Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity |
| NCT03098680 PRIME | PRIME (A094136) | Ph 1 | terminated | A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems |
| NCT02566252 | PUL-042-003 | Ph 1 | completed | Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROAIR DIGIHALER FDA Label Details
Indications & Usage
FDA Label (PDF)PROAIR DIGIHALER is FDA-approved to treat 3 conditions — same approved indications as PROVENTIL-HFA.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment